Shoulder InjuriesNCT05451550
The Effects of General Anesthesia and Combined Anesthesia in Controlled Hypotension During Arthroscopic Shoulder Surgery
A study testing Brachial plexus block, General anesthesia and Suprascapular nerve block in people with Shoulder Injuries and Shoulder Osteoarthritis, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial summary
Controlled hypotension is one of the important techniques used for facilitates the clarity of the surgical field during arthroscopic shoulder surgery. Brachial plexus or its branches block provides excellent analgesia during arthroscopic shoulder surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Injuries, Shoulder Osteoarthritis
- What is being tested?
- Brachial plexus block, General anesthesia and Suprascapular nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 17 Jul 2022to 29 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1) planned elective arthroscopic shoulder surgery, need controlled hypotension under general anesthesia; (2) aged 60-75 years; (3) ASA grade II or III; and (4) estimated operative time < 120 min.
Who cannot join
- (1) preoperative blood pressure systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg or pulse pressure ≥ 60 mmHg; (2) comorbidities of severe cardiovascular disease, including cardiac function grade III or IV, severe aortic stenosis, aortic valve insufficiency, severe coronary heart disease, bradycardia, and atrioventricular block above degree I; (3) history of cerebral infarction, Alzheimer's disease, or cerebrovascular incident; (4) liver and/or kidney dysfunction; (5) severe anemia, shock, hypovolemia, or respiratory dysfunction; (6) previous history of phlebitis or thrombosis, closed-angle glaucoma; and (7) BMI > 25 or < 18. Patients with intraoperative blood loss > 1500 mL or operation time > 4 h would be further excluded from the analysis.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Anesthesiology, General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: Comparison of Effects and Safety in Providing Controlled Hypotension During Arthroscopic Shoulder Surgery Between General Anesthesia and General Anesthesia Combined With Nerve Block
Controlled hypotension is one of the important techniques used for facilitates the clarity of the surgical field during arthroscopic shoulder surgery. Brachial plexus or its branches block provides excellent analgesia during arthroscopic shoulder surgery. To test the hypothesis that, during arthroscopic shoulder surgery, general anesthesia combined with nerve block could provide more stable hemodynamic index than general anesthesia. Patients undergoing arthroscopic shoulder surgery were enrolled and divided into 3 groups: general anesthesia group, general anesthesia combined with brachial plexus block, and general anesthesia combined with suprascapular nerve block group. The dosage of vasoactive drugs and anesthetics, parameters of perioperative bleeding, hemodynamic parameters, systemic oxygen metabolism, kidney functions, as well as procedure process and postoperative adverse reactions were recorded and compared between the groups.
Read the detailed description
Controlled hypotension is one of the important techniques used for minimizing bleeding and facilitates the clarity of the surgical field during arthroscopic shoulder surgery. Although surgical field visualization is important in arthroscopic shoulder surgery, the complications associated with controlled hypotension for surgery should be considered. The implementation of controlled hypotension requires a large amount of antihypertensive agents or anesthetics, it may cause instability of the circulatory system, organ hypoperfusion, or subsequent ischemic injury. Brachial plexus or its branches block provides excellent analgesia during arthroscopic shoulder surgery. However, few data are currently available in the literature evaluating brachial plexus or its branches block and controlled hypotension during arthroscopic shoulder surgery. To obtain more information on this topic, the investigators conducted this prospective randomized study to test the hypothesis that, during arthroscopic shoulder surgery, general anesthesia combined with nerve block could provide more stable hemodynamic index than general anesthesia.
Methods:
The inclusion criteria are (1) planned elective arthroscopic shoulder surgery, need controlled hypotension under general anesthesia; (2) aged 60-75 years; (3) ASA grade II or III; and (4) estimated operative time < 120 min. The exclusion criteria were (1) preoperative blood pressure systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg or pulse pressure ≥ 60 mmHg; (2) comorbidities of severe cardiovascular disease, including cardiac function grade III or IV, severe aortic stenosis, aortic valve insufficiency, severe coronary heart disease, bradycardia, and atrioventricular block above degree I; (3) history of cerebral infarction, Alzheimer's disease, or cerebrovascular incident; (4) liver and/or kidney dysfunction; (5) severe anemia, shock, hypovolemia, or respiratory dysfunction; (6) previous history of phlebitis or thrombosis, closed-angle glaucoma; and (7) BMI > 25 or < 18. Patients with intraoperative blood loss > 1500 mL or operation time > 4 h would be further excluded from the analysis.
The included patients were divided into 3 groups: general anesthesia group, general anesthesia combined with brachial plexus block, and general anesthesia combined with suprascapular nerve block group. For controlled hypotension during surgery, all patients were maintained with propofol/remifentanil in general anesthesia. An additional ultrasound-guided brachial plexus block or suprascapular nerve block were performed in general anesthesia combined with brachial plexus block or general anesthesia combined with suprascapular nerve block group. The dose of each agent was adjusted to maintain the mean arterial blood pressure (MAP) at 60 to 70 mm Hg and the BIS at 40 to 60. nicardipine and phenylephrine served mainly to control the target MAP, Norepinephrine and esmolol were also used as needed.
The dosage of vasoactive drugs (vasopressor-inotrope dose was calculated by adding norepinephrine equivalents of total norepinephrine, epinephrine, phenylephrine, and vasopressin dose used during surgery, using the following formula: total vasopressor-inotrope dose = [norepinephrine (µg/min) × min] + [epinephrine (µg/min) × min] + [(phenylephrine (µg/min) ×min) ÷ 10] + [vasopressin (U/h) × 8.33 × min]) and anesthetics, parameters of perioperative bleeding, hemodynamic parameters(blood pressure, heart rate, pulse oximetry), systemic oxygen metabolism, kidney functions, as well as procedure process and postoperative adverse reactions were recorded and compared between the groups. The incidence of postoperative complications (within 7 days, such as Organ dysfunction) were also recorded.
Statistical analysis and get conclusions.
- Conditions
- Shoulder Injuries, Shoulder Osteoarthritis
- Being tested
- Brachial plexus block, General anesthesia, Suprascapular nerve block
- Medical subject headings
- Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brachial plexus blockProcedure or surgery
Also called General anesthesia combined with brachial plexus block group
An additional ultrasound-guided suprascapular nerve block(0.375% ropivacaine) were performed before general anesthesia induction in general anesthesia combined with brachial plexus block group
General anesthesiaProcedure or surgery
General anesthesia were performed according to clinical routine: induction drugs: propofol, sufentanil, rocuronium, maintenance drugs: propofol, sevoflurane and remifentanil, Laryngeal mask ventilation.
Suprascapular nerve blockProcedure or surgery
Also called General anesthesia combined with suprascapular nerve block group
An additional ultrasound-guided suprascapular nerve block(0.375% ropivacaine) were performed before general anesthesia induction in general anesthesia combined with brachial plexus block group
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia group | Experimental | Patients were maintained with propofol/remifentanil in general anesthesia Receives: Procedure: General anesthesia |
| General anesthesia combined with brachial plexus block group | Experimental | An additional ultrasound-guided brachial plexus block were performed Receives: Procedure: Brachial plexus block; Procedure: General anesthesia |
| general anesthesia combined with suprascapular nerve block group | Experimental | An additional ultrasound-guided suprascapular nerve block were performed Receives: Procedure: General anesthesia; Procedure: Suprascapular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dosage of total vasopressor-inotrope dose between groups
The dosage of total vasopressor-inotrope dose (Calculate by formula) between the groups
Measured: 1 day
Secondary outcomes (3)
The dosage of anesthetics between groups
The dosage of propofol(milligram) and sevoflurane(milliliter) between groups
Measured: 1 day
Blood pressure between the groups
Blood pressure(millimeter of mercury) between the groups
Measured: 1 day
The incidence of postoperative complications
The incidence of postoperative complications (within 7 days, such as Organ dysfunction) between groups
Measured: 3 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start17 Jul 2022 (estimated)
- Primary completion29 Sep 2024 (estimated)
- Study completion29 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05451550
- Sponsor's protocol ID
- Gang202207
- Status last verified
- Jun 2022
- First submitted
- 20 Jun 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Effects and Safety in Providing Controlled Hypotension During Arthroscopic Shoulder Surgery Between General Anesthesia and General Anesthesia Combined With Nerve Block
- ClinicalTrials.gov ID
- NCT05451550
- Acronym / sponsor ID
- Gang202207
- Conditions
- Shoulder Injuries, Shoulder Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 17 Jul 2022 (estimated)
- Primary completion
- 29 Sep 2024 (estimated)
- Study completion
- 29 Nov 2025 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Controlled hypotension is one of the important techniques used for facilitates the clarity of the surgical field during arthroscopic shoulder surgery. Brachial plexus or its branches block provides excellent analgesia during arthroscopic shoulder surgery. To test the hypothesis that, during arthroscopic shoulder surgery, general anesthesia combined with nerve block could provide more stable hemodynamic index than general anesthesia. Patients undergoing arthroscopic shoulder surgery were enrolled and divided into 3 groups: general anesthesia group, general anesthesia combined with brachial plexus block, and general anesthesia combined with suprascapular nerve block group. The dosage of vasoactive drugs and anesthetics, parameters of perioperative bleeding, hemodynamic parameters, systemic oxygen metabolism, kidney functions, as well as procedure process and postoperative adverse reactions were recorded and compared between the groups.
Detailed description
Controlled hypotension is one of the important techniques used for minimizing bleeding and facilitates the clarity of the surgical field during arthroscopic shoulder surgery. Although surgical field visualization is important in arthroscopic shoulder surgery, the complications associated with controlled hypotension for surgery should be considered. The implementation of controlled hypotension requires a large amount of antihypertensive agents or anesthetics, it may cause instability of the circulatory system, organ hypoperfusion, or subsequent ischemic injury. Brachial plexus or its branches block provides excellent analgesia during arthroscopic shoulder surgery. However, few data are currently available in the literature evaluating brachial plexus or its branches block and controlled hypotension during arthroscopic shoulder surgery. To obtain more information on this topic, the investigators conducted this prospective randomized study to test the hypothesis that, during arthroscopic shoulder surgery, general anesthesia combined with nerve block could provide more stable hemodynamic index than general anesthesia.
Methods:
The inclusion criteria are (1) planned elective arthroscopic shoulder surgery, need controlled hypotension under general anesthesia; (2) aged 60-75 years; (3) ASA grade II or III; and (4) estimated operative time < 120 min. The exclusion criteria were (1) preoperative blood pressure systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg or pulse pressure ≥ 60 mmHg; (2) comorbidities of severe cardiovascular disease, including cardiac function grade III or IV, severe aortic stenosis, aortic valve insufficiency, severe coronary heart disease, bradycardia, and atrioventricular block above degree I; (3) history of cerebral infarction, Alzheimer's disease, or cerebrovascular incident; (4) liver and/or kidney dysfunction; (5) severe anemia, shock, hypovolemia, or respiratory dysfunction; (6) previous history of phlebitis or thrombosis, closed-angle glaucoma; and (7) BMI > 25 or < 18. Patients with intraoperative blood loss > 1500 mL or operation time > 4 h would be further excluded from the analysis.
The included patients were divided into 3 groups: general anesthesia group, general anesthesia combined with brachial plexus block, and general anesthesia combined with suprascapular nerve block group. For controlled hypotension during surgery, all patients were maintained with propofol/remifentanil in general anesthesia. An additional ultrasound-guided brachial plexus block or suprascapular nerve block were performed in general anesthesia combined with brachial plexus block or general anesthesia combined with suprascapular nerve block group. The dose of each agent was adjusted to maintain the mean arterial blood pressure (MAP) at 60 to 70 mm Hg and the BIS at 40 to 60. nicardipine and phenylephrine served mainly to control the target MAP, Norepinephrine and esmolol were also used as needed.
The dosage of vasoactive drugs (vasopressor-inotrope dose was calculated by adding norepinephrine equivalents of total norepinephrine, epinephrine, phenylephrine, and vasopressin dose used during surgery, using the following formula: total vasopressor-inotrope dose = [norepinephrine (µg/min) × min] + [epinephrine (µg/min) × min] + [(phenylephrine (µg/min) ×min) ÷ 10] + [vasopressin (U/h) × 8.33 × min]) and anesthetics, parameters of perioperative bleeding, hemodynamic parameters(blood pressure, heart rate, pulse oximetry), systemic oxygen metabolism, kidney functions, as well as procedure process and postoperative adverse reactions were recorded and compared between the groups. The incidence of postoperative complications (within 7 days, such as Organ dysfunction) were also recorded.
Statistical analysis and get conclusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| General anesthesia group | Experimental | Procedure: General anesthesiaPatients were maintained with propofol/remifentanil in general anesthesia |
| General anesthesia combined with brachial plexus block group | Experimental | Procedure: Brachial plexus block, Procedure: General anesthesiaAn additional ultrasound-guided brachial plexus block were performed |
| general anesthesia combined with suprascapular nerve block group | Experimental | Procedure: General anesthesia, Procedure: Suprascapular nerve blockAn additional ultrasound-guided suprascapular nerve block were performed |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (1) planned elective arthroscopic shoulder surgery, need controlled hypotension under general anesthesia; (2) aged 60-75 years; (3) ASA grade II or III; and (4) estimated operative time < 120 min.
Key exclusion criteria (1 listed)
- (1) preoperative blood pressure systolic ≥ 160 mmHg or diastolic ≥ 100 mmHg or pulse pressure ≥ 60 mmHg; (2) comorbidities of severe cardiovascular disease, including cardiac function grade III or IV, severe aortic stenosis, aortic valve insufficiency, severe coronary heart disease, bradycardia, and atrioventricular block above degree I; (3) history of cerebral infarction, Alzheimer's disease, or cerebrovascular incident; (4) liver and/or kidney dysfunction; (5) severe anemia, shock, hypovolemia, or respiratory dysfunction; (6) previous history of phlebitis or thrombosis, closed-angle glaucoma; and (7) BMI > 25 or < 18. Patients with intraoperative blood loss > 1500 mL or operation time > 4 h would be further excluded from the analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brachial plexus blockAlso: General anesthesia combined with brachial plexus block groupAn additional ultrasound-guided suprascapular nerve block(0.375% ropivacaine) were performed before general anesthesia induction in general anesthesia combined with brachial plexus block group | Procedure or surgery | General anesthesia combined with brachial plexus block group |
| General anesthesiaGeneral anesthesia were performed according to clinical routine: induction drugs: propofol, sufentanil, rocuronium, maintenance drugs: propofol, sevoflurane and remifentanil, Laryngeal mask ventilation. | Procedure or surgery | General anesthesia combined with brachial plexus block group, General anesthesia group, general anesthesia combined with suprascapular nerve block group |
| Suprascapular nerve blockAlso: General anesthesia combined with suprascapular nerve block groupAn additional ultrasound-guided suprascapular nerve block(0.375% ropivacaine) were performed before general anesthesia induction in general anesthesia combined with brachial plexus block group | Procedure or surgery | general anesthesia combined with suprascapular nerve block group |
Primary outcome
The dosage of total vasopressor-inotrope dose between groups
Time frame: 1 day
The dosage of total vasopressor-inotrope dose (Calculate by formula) between the groups
3 secondary outcomes
The dosage of anesthetics between groups
Time frame: 1 day
Blood pressure between the groups
Time frame: 1 day
The incidence of postoperative complications
Time frame: 3 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Shoulder Injuries
Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
RecruitingObservational study
Duration of Immobilization After Reverse Total Arthroplasty for Proximal Humerus Fractures
Proximal Humeral Fracture, Reverse Total Shoulder Arthroplasty
Not yet recruiting
TECAR With Shoulder Chronic Shoulder Impingement Syndrome
Shoulder Impingement Syndrome
Not yet recruiting
"Effectiveness of a Telerehabilitation Program Versus a Conventional Rehabilitation Program in Patients With Subacromial Pain"
Subacromial Impingement Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brachial plexus block, General anesthesia and Suprascapular nerve block in people with Shoulder Injuries and Shoulder Osteoarthritis, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Ma, doctor (13709519220 ext. +86, magang2671@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dosage of total vasopressor-inotrope dose between groups (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2022.